Accuracy Assessment of Beddr Oximeter

Oximetry Clinical Trial

Official title:

Beddr Sleep SpO2 Equivalency Calibration Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03710993
• Other study ID #: PR 2018-290
• Status: Completed
• Start date: July 30, 2018
• Est. completion date: August 3, 2018

Study information

• Verified date: October 2018
• Source: Hancock Medical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Accuracy performance of Beddr oximeter

Description:

This study will evaluate the accuracy of the Beddr sleepTuner oximeter compared to a transfer standard and multiple reference devices.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: August 3, 2018
• Est. primary completion date: August 3, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Subject must have the ability to understand and provide written informed consent

• Adult subjects 18 up to 50 years of age

• Subject must be willing and able to comply with study procedures and duration

• Subject is a non-smoker or who has not smoked within 2 days prior to the study.

• Male or female of any race

• Subject demographics include a range of skin pigmentations, including at least 1 darkly pigmented subjects or 15% of the subject pool, whichever is larger.

Exclusion Criteria:

• Subject is considered as being morbidly obese (defined as BMI >39.5)

• Compromised circulation, injury, or physical malformation of fingers, toes, hands, ears or forehead/skull or other sensor sites which would limit the ability to test sites needed for the study. (Note: Certain malformations may still allow subjects to participate if the condition is noted and would not affect the particular sites utilized.)

• Females who are pregnant, who are trying to get pregnant or who have a urine test positive for pregnancy on the day of the study

• Subjects with known respiratory conditions such as:

• uncontrolled / severe asthma,

• flu,

• pneumonia / bronchitis,

• shortness of breath / respiratory distress,

• unresolved respiratory or lung surgery with continued indications of health issues,

• emphysema, COPD, lung disease

• Subjects with known heart or cardiovascular conditions such as:

• Hypertension: systolic >140mmHg, Diastolic >90mmHg on 3 consecutive readings.

• have had cardiovascular surgery

• Chest pain (angina)

• heart rhythms other than a normal sinus rhythm or with respiratory sinus arrhythmia

• previous heart attack

• blocked artery

• unexplained shortness of breath

• congestive heart failure (CHF)

• history of stroke

• transient ischemic attack

• carotid artery disease

• myocardial ischemia

• myocardial infarction

• cardiomyopathy

• Self-reported health conditions as identified in the Health Assessment Form

• diabetes,

• uncontrolled thyroid disease,

• kidney disease / chronic renal impairment,

• history of seizures (except childhood febrile seizures),

• epilepsy,

• history of unexplained syncope,

• recent history of frequent migraine headaches,

• recent head injury within the last 2 months,

• cancer / chemotherapy

• Subjects with known clotting disorders

• history of bleeding disorders or personal history of prolonged bleeding from injury

• history of blood clots

• hemophilia

• current use of blood thinner: prescription or daily use of aspirin

• Subjects with Severe contact allergies to standard adhesives, latex or other materials found in pulse oximetry sensors, ECG electrodes, respiration monitor electrodes or other medical sensors

• Unwillingness or inability to remove colored nail polish or non-clear artificial nails from test digits.

• Other known health condition, should be considered upon disclosure in health assessment form

Related Conditions & MeSH terms

• Oximetry

Intervention

Device:
• oximeter
Participants breathe a controlled gas mixture to induce several reduced oxygen states while oximeter measurements are taken for comparison to corresponding transfer standard and reference devices to assess oximeter calibration and accuracy.

Locations

Country	Name	City	State
United States	Clinimark	Louisville	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
Hancock Medical, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SpO2 accuracy	Collect and analyze data to assess SpO2 calibration and accuracy	60 minutes